System and method for regulatory intelligence

ABSTRACT

A system and method are disclosed for locating, collecting, collating, analyzing, and reporting on summarized data that is generated from regulatory compliance matter data. Data is collected and compiled from multiple sources, including government databases, web pages, and regulatory documents; These collected data are consolidated and reconciled. A single topic record is created for a person, company, or product. Duplication and redundancy within the information are reduced. Corrections in data format are made for inconsistencies that exist between different information sources. Broad and/or narrow searches are enabled with the retrieval of information and/or relevant documents. The integrated data and associated analyses can be presented in reports that can be made accessible through a LAN, a WAN, a desktop, and/or a web interface.

CROSS REFERENCES TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 60/609,960, filed on Sep. 15, 2004, titled “System and Method ForRegulatory Intelligence”, which is incorporated herein by reference.

FIELD

The present invention relates generally to data consolidation, and ismore particularly related to the consolidation of and reporting onregulatory data, where the reporting can be used for regulatoryintelligence.

BACKGROUND

With the introduction and rapid adoption of the Internet and the WorldWide Web, huge amounts of data and information are increasingly moreaccessible. A variety of companies have developed “products” consistingof specific information topics.

Commercial entities are not alone in taking advantage of thistechnology. Regulatory authorities in federal, state, and localgovernments are providing citizens access to frequently requestedinformation via the Internet. The Freedom of Information Act (FOIA) hasallowed access to a wide variety of documents and regulatory records,making these available upon request. More and more, these documents andregulatory records are made available through government websites.

Although the ready availability of regulatory information hassignificantly improved over the past decade, the ability to use theinformation in a meaningful way remains limited. Compliance andenforcement data that are collected and used by regulatory agencies arehighly compartmentalized according to the agency responsible forcollecting it. There is little consolidation of inter-agency regulatoryinformation, making it difficult to quickly and easily performregulatory performance assessments for either the regulatory agencies orthe regulated party. Even regulators are forced to access multipleinformation sources to completely characterize regulatory performanceand compliance history.

Consolidation of the many data repositories of regulatory agencies isproblematic for several reasons. As each agency has developed theirdatabase systems to meet their own needs, the data format, userinterface, and data definitions are not necessarily consistent withother agency information systems. Correcting this condition to allowinter-agency access under a single compatible system would be expensive,time-consuming, and resource intensive. Government agencies have littleavailable resources to accomplish such a consolidation.

For regulated industries, the problem is similar. Enforcement focus issubject to change, depending upon the environment. For instance,regulatory agencies may choose to focus closely on enforcement ofcertain environmental laws following a much publicized chemicalaccident. Enforcement focus may also change for less obvious reasons. Aproblem encountered by one manufacturer may alert the regulators toscrutinize areas that have not previously been examined. Without rapidaccess to good regulatory intelligence, both companies and regulatorsmay be unprepared to manage a public health issue.

It is difficult to stay current with the constantly changingrequirements and compliance trends. Today, there is not a timely,efficient, and effective way to stay current. Regulatory research intospecific areas is difficult and time-consuming. This research requireshighly specialized knowledge of the regulatory processes and theavailable information sources.

The diverse nature of the information sources discussed above makesintegration of the data resource intensive and costly. Accordingly,there would be an advantage in the art to provide a system and methodfor addressing these issues by providing an easy to use, single pointreference that enables research of or relating to people, products,companies, regulators and/or the regulatory environment. Moreover, sucha system and method would provide ready access to understandableregulatory intelligence to facilitate the regulatory process, and tobenefit related government agencies, industry, and consumers.

SUMMARY

A system and method are provided for locating, collecting, collating,analyzing, and reporting data generated about regulatory compliancematters, turning disorganized data into regulatory intelligence. Thesystem and method can collect and compile data from multiple sources,including government databases, web pages, regulatory documents, anddata from other sources. A consolidation and reconciliation is made ofthe collected data. A creation is also made of an indexed topic recordfor a person, company, and/or product, thereby reducing duplication andredundancy within the information. This allows seemingly unrelatedrecords to be laterally related for broadening of on-demand queryparameters. Corrections are also made to data format in consistenciesthat exist between different information sources. Broad and/or narrowsearches with information and relevant document retrieval are enabled.The integrated data and associated analyses can be presented in reportsthat can be accessible through a LAN, a WAN, a desktop, and/or a webinterface.

These and other features of the present invention will become more fullyapparent from the following description and appended claim, or may belearned by the practice of the invention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

In order that the manner in which the above-recited and other advantagesand features of the invention are obtained, a more particulardescription of the invention briefly described above will be rendered byreference to specific embodiments thereof which are illustrated in theappended drawings. Understanding that these drawings depict only typicalembodiments of the invention and are not therefore to be consideredlimiting of its scope, the invention will be described and explainedwith additional specificity and detail through the use of theaccompanying drawings in which:

FIG. 1 shows an exemplary implementation of a Regulatory IntelligenceSystem (RIS);

FIG. 2 shows steps in a process within a Data Converter (DC) within theRIS of FIG. 1;

FIG. 3 shows steps in a process within a Data Integrator (DI) within theRIS of FIG. 1;

FIG. 4 shows steps for searching within a Main Processor (MP), includingthe Transformed Data Master Record (TDMR) within the RIS of FIG. 1;

FIG. 5 shows an example of a query menu for regulatory informationrelating to clinical research;

FIG. 6 shows a sample of the records returned following a query, whereeach indicator shown as “Yes” informs a user where matching informationexists;

FIG. 7 shows respective examples of detail in a single information typefor a regulatory warning letter;

FIG. 8 shows a sample report for a drug reflecting consolidated datafrom multiple sources;

FIG. 9 shows a sample Regulatory Performance report for a medicaldevice;

FIG. 10 depicts examples of a Remote Access Model for the RIS of FIG. 1;and

FIG. 11 depicts examples of a Resident Access Model for the RIS of FIG.1.

DETAILED DESCRIPTION

Implementations provide a system and method for locating, collecting,collating, analyzing, and reporting on summarized data that is generatedfrom regulatory compliance matter data. The regulatory compliance matterdata is collected and compiled from multiple sources, includinggovernment databases, web pages, and regulatory documents. The collectedand compiled regulatory compliance matter data is consolidated andreconciled. A single topic record is created for a person, company, orproduct. Duplication and redundancy within the regulatory compliancematter data are reduced. Corrections in data format are made forinconsistencies that exist between different information sources.Searches of varying scope are enabled with the retrieval of information.The consolidated and reconciled regulatory compliance matter data, andassociated analyses, can be presented in user-selected reports.

A regulatory information management system (RMS), in variousimplementations, is provided. The RMS provides for the management ofregulatory information that is obtained from a plurality ofheterogeneous information sources. The RMS includes means for a queryinga plurality of sources to collecting information. The querying means caninclude a query engine that enables searches of the plurality of sourcesto derive specific information specified to the query engine. Thesesources include, but are not limited to, a plurality of databasesresiding on respective geographically dispersed servers. Each databaseis a repository for regulatory information, including information frompublic, governmental, and private sources. Each server, and the meansfor collecting information, is in communication by one or more networks.

The RMS includes means for integrating the collected information into apredetermined form. The integrating means may also include means forreconciling the collected information prior to the integration thereofit into the predetermined form. The reconciling means can also locateduplicate data and eliminate redundancies, as well as consolidate dataretrieved from the plurality of heterogeneous information sources so asto be conformed into one or more predetermine record layouts or formats,where each record has one or more predetermined fields.

Optionally, the RMS may include means for summarizing the collectedinformation in the predetermined form, and means for analyzing thecollected information in the predetermined form. Further, the RMS mayinclude a means for reporting, The reporting means may report thecollected information into the predetermined form, the summarizedcollected information in the predetermined form, the analyzed collectedinformation in the predetermined form, and/or the summarizes andanalyzed collected information in the predetermined form.

In general, the reporting means reports the results of informationderived from information specified to the query engine. The results arethe result of integrating the collected information into a predeterminedform. The collected information in the predetermined form may also bereconciled prior to being integrated into the predetermined form. Also,an analysis and summary of the collected information by be performedprior to the reporting thereof by the reporting means. Alternatively,the analysis and summary of the collected information by be performedprior to the integration of the collected data into the predeterminedformat.

In that access to, and retrieval of data from, the plurality ofheterogeneous information sources may require access privileges andauthorization for same, the RMS may also include means for performingauthorization for access and for retrieval of data from the plurality ofheterogeneous information sources. The authorization and retrieval meansmay perform one or more steps for each of the heterogeneous informationsources. Each heterogeneous information source can be a local datasource, a web-based data source, a commercial database, a hard copydocument database, or a database having data in another electronicformat.

The RMS integrates the collected information into the predeterminedform, where the predetermined form has a consistent electronic form,such as a consistent tabular or other matrix format. Further, the RMScan operate upon the collected information, given a predetermined errordetermination and correction routine, in order to correct the collectedinformation. The predetermined error determination and correctionroutine will preferably use a standard that is recognized by an industryassociation that corresponds to the regulatory data being collected.

In order to place the collected information into the predetermined form,the collected information can be normalized into a predetermined formatwhich includes a predetermined presentation format. The data in thepredetermined form can be in one or more predetermined fields. As such,the data in the predetermined form and predetermined fields can beintegrated so as to link, or otherwise be associated with, a subject, acategory, or another predetermined field. Each heterogeneous informationsource can be, for instance, a database that is comprised of relationaltables that associate the data and the data fields therein with the dataand the data fields of another database that is also comprised ofrelational tables.

The reporting means can display data associated, according to apredetermined standard, with a single subject. The display can includethe presentation of data retrieved from the plurality of heterogeneousinformation sources. Moreover, the display of the retrieved data canpresented via a web-based interface, a locally accessed server ordesktop interface, or a telecommunications access.

In other implementations, a computer readable medium that includesinstructions. The instructions, when executed by a computer incommunication with one or more databases of regulatory information,locates and retrieves the regulatory information in the one or moredatabases, consolidates the retrieved regulatory information, analyzesthe consolidated regulatory information, and outputs a report of theanalysis of the consolidated regulatory information. The executedinstructions can also perform one more management functions upon theregulatory information of the one or more databases of regulatoryinformation.

FIG. 1 depicts an exemplary process illustrating an embodiment of aRegulatory Intelligence System (RIS) 10. The RIS 10 includes a DataConverter (DC) 16, a Data Integrator (DI) 17, a Transformed Data MasterRecord (TDMR) 21, an Authentication Module (AM) 24, a Data Analyzer (DA)19, a User Automation Module (UAM) 26, a Query Engine (QE) 20, a ReportGenerator (RG) 22, and a Main Processor (MP) 18.

The RIS 10 is controlled through an intuitive user interface (UI) bywhich the user composes and submits queries 23; reviews the informationfound; selects report preferences; and outputs (e.g.; prints) reports.Users are identified and their access is authenticated through the AM 24upon requesting access to the RIS 10 via assigned user passwords andidentifiers. The identifiers define the user's level of access and thetypes of information they have permission to access. For example, a usermay only be interested in accessing regulatory information relating tomedical devices. As such, other regulatory information categories (i.e.,pharmaceutical or environmental hazards) would not be accessible.

Throughout the UI, as shown in FIG. 6, access to the Help function 74 isavailable to assist the user in understanding the information found andthe navigational icons 73 assist the user in navigating within the RIS10. The RIS 10 includes a glossary of terms that explains thesignificance of each information type, as well as any commonly usedacronyms. Also included are features that allow the users to requestdocuments that are not included in the RIS 10; submit suggestions forenhancing or adding features 75; and report bugs 76 encountered whileusing the RIS 10.

The RIS 10 includes a plurality of heterogeneous information sources,each of which may have different information types (e.g.; differentfiles, different records with each file, different fields within eachrecord, etc.). Some information types are extracted from public websites11, where this information may reside within the text of a web page orin a downloadable file. For example, the Office of Inspector General(OIG) publishes a list of persons or entities that have been excludedfrom participation as a provider in the Medicare/Medicaid program. Alsoby way of example, adverse event reports for medical devices aretypically contained in a downloadable file that can be imported into adatabase.

Some databases are not available on a website, but are available forpurchase through specific government or private resources, such ascommercial databases 12. For example, establishments and individuals whorequest and obtain a permit to manufacture or prescribe controlledsubstances are listed in a purchasable dataset from the US government.

Both documents and data may be obtained through a Freedom of InformationAct (FOIA) request 13. FOIA made available certain types of informationthat is considered to be “public” information. A written request sent tothe appropriate FOIA office enables documents and data that are notpublished on public Web pages to be accessed and incorporated into theRIS 10. The user can generate this request directly through the RIS 10.

A variety of other documents or information sources 14 can also beincluded in the RIS 10. For example, news releases or curriculum vitaemay also be included in the RIS 10. These items are retrieved from avariety of public sources.

Multimedia items 15 may also be incorporated into the RIS 10. Forexample, photographs of products or people may be located from publicsources and incorporated.

Using one or more components of RIS 10, each information source 11-15can be checked at one or more predetermined intervals to determine ifnew or changed information is available. The frequency of the checks isdetermined by the nature of the data and the information source. Somesources are updated daily, while others may be updated annually.

Each information source may contain one or more information types. Eachinformation type may have one or more sources. The sources may be indifferent forms or locations sponsored by different agencies or groups.As seen in FIG. 2, Data retrieved 30 by the DC 16 may be in one of manydifferent formats, ranging from a direct database download to a hardcopy of a document.

As the information is retrieved 30, the source and date that the datawas obtained is recorded, although the user may not have access to thisinformation. This allows traceability of the data for sourceverification and information history.

Each information type 28 has its own characteristics and style. Thus,the data from each source has a defined set of rules and a regimen forconversion 32 within the DC 16. Each information type 28 can beconverted into a consistent digital format suitable for importing intoan electronic database. For example, data retrieved may be in a portabledata format (.PDF) or in a tab-separated text format. A table publishedon a web page is extracted, broken down into specified data fields, andconverted into a spreadsheet or into tab-separated text. Appropriateconversion 32 is completed prior to the data correction 34 process.

Data corrections are made 34 for data inconsistencies to allowconsolidation and integration of data from multiple sources. Errors canexist in data sets obtained from an information source. For example, thedata listing for clinical investigators of drug clinical trials caninclude multiple listings that begin with a sequence of “ZZZ”. If thisdata was not corrected, searches for “Jack Smith” would not recognize arecord for “Jack ZZZSmith”. A means for identifying such errors andcorrecting them, such as one or more predetermined filters, can beprovided by software and/or hardware. As new discrepancies arediscovered, the system and method can add, alter, or delete one or morepredetermined filters so as to identify and correct discrepancies asthey are identified.

Over time, the information sources may change the way that theinformation is collected and/or reported. For example, informationsources are increasingly converting their frequently used information(for example, adverse event reports or establishment registrations) intoa searchable format via a web interface. The DC 16 includes internalchecks that detect changes that occur in order to appropriately adjustthe conversion (DC 16), integration (DI 17) and subsequent reporting (RG22).

Inconsistency in terminology is likely across heterogeneous informationsources (e.g.; disparate data sources), which may be due to each datasource having been created with a specific use in mind that differedfrom that of other data sources. These data must then be normalized 36before data integration 17. One source of New Drug Application numbers,for example, may include a two digit year followed by a dash in front ofa five digit number (i.e.; 93-12345). Another source may omit the dashand add an “N” at the beginning of the number (i.e.; N96312345). Datafields such as these are considered “key fields” and must be in aconsistent form for accurate integration and cross-referencing.

As regulatory requirements change, an entire scheme of information maychange. The DC 16 detects and allows compensation for these changes. Forexample, prior to 1996, adverse events relating to medical devices werereported under a specified set of requirements. Reports made to the Foodand Drug Administrations required specific information to be included inthe report. A new system was introduced in 1996 that increased theamount of information collected and altered the regulatory requirementsfor reporting. When changing from the old system to the new system, aset of new rules and a conversion regimen 32 are desirable to maintaincontinuity within the RIS 10.

The DI 17, as shown in FIG. 3, reconciles the converted data 40 betweenheterogeneous (disparate) information sources by performing cross-checksbetween duplicate entries using tools such as pattern checks. Dataquality checks 42 are incorporated and performed to verify that anyupdates to the data will reflect appropriate data types. Fields arechecked against pre-defined criteria to determine if the contents matchthe expected data type. For example, date fields are checked to verifythat the contents are a recognizable date. Dates of regulatorysubmissions, for example, are checked against the approval dates toverify that the approval came after the submit date. When discrepanciesare noted, the DI 17 can either correct the format, or send an errormessages to alert an attendant or the administrator, who then intervenesto examine and resolve the discrepancy appropriately.

Historical information will preferably be kept, even though aninformation source may remove its “old” data, perhaps through a dataattrition process. For instance, when an information type is updated,that information type may be completely reloaded (e.g.; replacing all ofthe previous data), or only new/changed information may be added.Duplicate information is identified and, as appropriate, eliminated 44.The remaining data is integrated 46 into an indexed record 46. Thisrecord is used to update or replace 48 the records contained in theTransformed Data Master Record (TDMR) 21.

The MP 18 includes the TDMR 21, the QE 20, the UAM 26, and the DA 19.Within the TDMR 21 each information type 28 is segregated into datacontainers comprised of consolidated records. This segregation enablesthe user to make more focused queries within only those data containersthat are relevant to the subject of the query.

A user interface (UI), such as is seen in FIG. 5, allows the user toselect a subject for the user's query 23. The subject of the user'squery 23 can be a person, a company, a product, and/or a regulatoryperformance measure. The user can allow the QE 20 to search allinformation types, by selection of a “Fast Find” function 60, or onlythose believed relevant to the subject. A global query can be made toall information types or it can be narrowed to specific categories ofinformation, such as clinical research, pharmaceuticals or medicaldevices.

FIG. 5 shows an example of a screen for submitting a query in the areaof clinical research. The user can elect to search all relevantinformation types with a single query (“FAST Find” 60). For example, ifthe query subject of the user's query 23 is a person involved withclinical research, relevant information may only be contained ininformation types 28 (e.g.; limited to only Info Types 2, 3, 4, 6, and12 seen in FIG. 4). The Query Engine (QE) 20 will execute a searchthrough the appropriate information types. In this manner, search timeis minimized because the QE 20 can use one or more predetermined filtersto identify those information types that may contain records relating tothe query subject of the user's query 23.

Correspondingly, if the user only wishes to know whether the subject hasbeen disqualified, using an FDA disqualification function 62, by the FDAas a clinical investigator, the query can be directed at this singleinformation type. Each information type may be queried for more detailedqueries within a selected information type. Examples of other criteriathat can be included in the query include, but are not limited to:geographical location; dates; or date ranges and license numbers.

A User Query 23 performed for a person's name as the subject wouldreturn any information associated with that person. For example, FIG. 6shows a search for several physicians within the clinical researchcategory. Records returned may reflect participation in clinical trials77; inspections conducted by FDA or other government oversight groups79; regulatory warning letters issued 80; records relating to scientificmisconduct in research 82; and debarment status 83.

In FIG. 6, one possible display of query results show that Nancy Jones,MD, PhD 71 has been a clinical investigator on one or morepharmaceutical clinical studies 77; has received a “Notice of Initiationof Disqualification Proceedings and Opportunity to Explain” (NIDPOE)letter 78; a regulatory warning letter 80; and has been eitherdisqualified or restricted 81 by the FDA. An indicator (“Yes” in theexample) tells the user that there is a match in an information type. Amouse click on the indicator opens a window that provides a quick reviewof the matching record. FIG. 7 shows two examples of a warning lettersummary record 90. If the actual letter is available, a button 91indicates it is immediately available. A mouse click will open theletter for detailed viewing.

A User Automation Module (UAM) 26 seen in FIG. 4 allows the user torepeat a specific search by saving the search criteria. During afollow-up session, the user can review previous searches and repeat themas desired. Automated repeat searches can be requested, with theresulting report provided to the user via e-mail and/or directly to apre-defined printer in their pre-selected, preferred format. Theserepeat queries can be “on demand” or scheduled at specified intervals.

Data analysis 19 varies, depending upon the subject of the query. Theanalysis may consist of simple tabulations or more complex summaries andsub-summaries. For example, a search for a person's name may return asimple statement of the establishment registrations for which they arethe designated official contact. Regulatory Performance searches mayrequire more detailed analysis (FIG. 9). For example, to examine thenumber and nature of warning letters issued for GMP violations in 1999compared to those issued in 2000, 2001, 2002, and 2003, the system willsummarize the five years separately and will also report the overalltotals, sorted by the subject area of the warning letter.

The Report Generator (RG) 22 can generate reports in a form that isunderstandable to both regulatory and non-regulatory professionals. Theuser can select from a list of standard report formats that reflect theinformation types related to the query subject. Custom reports can alsobe requested. The UAM 26 can “remember” the sorting order and reportformat selected, making it easier to obtain updates or retrieve previousreports. It can also save a copy of the criteria used in the query, thesorting order specified, and a copy of the report.

A report based on the name of a prescription drug would receive a report(FIG. 8) including information such as the sponsor company who hasapproval to market the drug 100; orphan drug status 101; type of reviewthe drug underwent (e.g., expedited, routine) 102; regulatory history(product approvals 103); the Summary of Safety and Effectivenessdocuments for the drug 104; label changes made for safety reasons 105;product recalls 106; and regulatory warning letters issued 107 about thedrug.

The User Query 23 subject may also be Regulatory Performance (FIG. 9) inspecified areas. The review history of a specific type of productprovides insight into the number of submissions approved for aparticular device 110; how long the product was under regulatory reviewby a particular reviewing group 111. It may be beneficial to the user toretrieve the number and nature of recalls 112 or regulatory warningletters 113 issued on a particular topic as these provide insight intoenforcement patterns and trends within a particular regulatory agency.

The RG 22 can report all information or only new information since theprevious report was generated. For example, a report of all premarketnotifications submitted by a particular company can be scheduled for the10^(th) day of each month. After the first report generated, subsequentqueries can return only new submissions that have been cleared since thelast report. An e-mail notification function in the UAM 26 either alertsthe user to retrieve the report or e-mails an electronic version to theuser.

Access to the RIS 10 is provided through a variety of hardwareconfigurations. Examples given here are some of the possibleconfigurations and are not meant to show all possible solutions. Asshown in FIG. 10, the RIS 10 resides on a central server or mainframe120, 130. The MP 18 controls user access 24 and queries (20, 23) to theTDMR 21 as well as the data analysis 19 and report generation 22. Accessto the MP 18 can either be through a Remote Access Model (FIG. 10) or aResident Access Model (FIG. 11).

The Remote Access Model shown in FIG. 10 allows users direct access tothe MP 18 via an internet or other suitable connection. Queries are sentfrom the remote location to the MP 18 where they are processed and aselected report is returned to the user. This remote access can bethrough an individual desktop 121 or laptop computer 122, or through anetwork 123.

The Resident Access Model shown in FIG. 11 uses a local mainframe orserver 130, desktop PC 131 or laptop 133 as the MP 18. The MP 18components, including the QE 20, the TDMR 21, and the RG 22, arephysically transferred via download or other media 134 (e.g., CD-ROM, orDVD) to storage (e.g.; a hard disk) that is resident with the user. TheTDMR 21 is then updated with scheduled downloads from the RIS 10.

One type of regulatory information that can be retrieved and reported byuse of User Query 23 is regulatory performance measurement data. A usercan define the regulatory performance measurement data that is to becalculated and displayed. A user can also employ the User Query 23 todefine the specific subject or subject type that is to be analyzed byRIS 10. Queries submitted via the User Query 23 are authenticatedagainst defined criteria to allow access to specific data types andsources within RIS 10. As such, the User Query 23 allows a user tosubmit a query and retrieve the results of a search within a specifiedsubject type or category. Multiple criteria searches within a pluralityof disparate data records can be performed according to userspecifications with the User Query 23. Searches can be performed withina user specified subset of the disparate data sources. The searches canbe limited by RIS 10 to a specified subset of disparate data records towhich the user has access. In one such search specified by a user, thesearch criteria can be retrieved from a plurality of data tables, wheredata is retrieved based upon a received search criteria. When data isretrieved that matches the received search criteria, that data isconsolidated for reporting the results of the user's query. Thereporting can include displaying the consolidated data in a defaultformat or in a format specified by the user.

The search request using RIS 10 can be presented to the user in multipleaccess venues. These venues include venues in which the user initiates asearch request via a web-based interface, or via local access through aLAN or WAN. The user initiated search requests can be displayed via aweb-based interface or via local access through a LAN or WAN.

Data retrieved by RIS 10 can be aggregated and organized forincorporating into one or more types of reports. The data that isretrieved and displayed, when so specified by a user, can be specific tothe subject type and nature of the user's query. For instance, the usercan specify that regulatory performance reports are to be generatedwithin a user specified subject type.

Searches can be authenticated based on user and subject type, where theauthentication function specifies the level of a user's access to bothsubject type and data. Moreover, the authentication function can specifythe data sources that are accessible to the user (e.g.; the searchrequests can be authenticated based only on the user and the subjecttype). A report that displays request submitted by a user via user query23 can be authenticated based on the user and the subject type. The typeof report can be tables, charts and/or graphs, each of which can becreated from the data that was retrieved and summarized by RIS 10.

The user query 23 allows a user to specify a report that is generatedupon user selected time intervals or upon the occurrence of userselected specific events. Also, RIS 10 allows the user to specify thegeneration of reports based on searches conducted upon request by theuser, or to specify criteria for searches to be conducted upon theavailability of updated information in one or more of the disparate datasources, or to specify the generation of reports based on searchesconducted upon the availability of updated information in one or more ofdisparate data sources.

Pre-defined searches can be retained by RIS 10 for execution accordingto user-specified terms. The pre-defined searches can be used togenerate reports that are also retained by RIS 10 for display accordingto the user specified terms.

RIS 10 can generate notifications of the availability of new informationfrom one or more different data sources. As such, a UI for RIS 10 allowsthe user to define the types of notifications that the user requiresbased on the different data sources. The user, for instance, can definethe types of notifications that the user requires based on a specifiedsubject, or the time interval of the notifications that the userrequires, or which specific events for which notifications are requiredby the user. The user can also define the nature of the delivery of thenotification.

CONCLUSION

The disclosed system and method, in their various embodiments andalternatives discussed above, solves resource use and financial problemsinherent in integrating diverse regulatory information sources, andproduces a consolidated and reconciled collection of data within asingle topic record in which duplication, redundancy, and data formatinconsistencies are reduced. The single topic record can beadvantageously used to produce reports in a form that is understandableto both regulatory and non-regulatory professionals.

While preferred embodiments of this invention have been shown anddescribed, modifications thereof can be made by one skilled in the artwithout departing from the spirit or teaching of this invention. Theembodiments described herein are exemplary only and are not limiting.Many variations and modifications of the method and any apparatus arepossible and are within the scope of the invention. One of ordinaryskill in the art will recognize that the process just described mayeasily have steps added, taken away, or modified without departing fromthe principles of the present invention. Accordingly, the scope ofprotection is not limited to the embodiments described herein, but isonly limited by the claims that follow, the scope of which shall includeall equivalents of the subject matter of the claims.

1. A reporting system for regulatory intelligence information from aplurality of heterogeneous regulatory information sources implemented ona computer system, the reporting system comprising: a processor; aninformation retrieval system that collects information from theplurality of heterogeneous regulatory information sources, wherein theinformation retrieval system collects information from multiple sourcesincluding local and web-based data sources, commercial databases, andhard copy documents, wherein the information retrieval system isconfigured to perform authorization to access and retrieve data from thedatabase of consolidated heterogeneous regulatory information sources; adata integrator that reconciles the collected information and integratesit into a common form, wherein the data integrator converts thecollected information into one or more appropriate data table whilemaintaining links to related data, wherein the data integrator checksthe collected information for errors by utilizing a predeterminedstandard defined by an Administrator, wherein the data errors arecorrected according to standard, established criteria established by theAdministrator; a database of consolidated heterogeneous regulatoryinformation sources in which the collected and integrated information isstored; a query engine receiving a specification of a search of theinformation from the database of consolidated heterogeneous regulatoryinformation sources; and a report generator that outputs the results ofa query by the query engine of the database of consolidatedheterogeneous regulatory information sources as processed by the dataintegrator and data analyzer, wherein the data integrator forms thedatabase of consolidated heterogeneous regulatory information sourcesfrom the collected information, the database comprises relational tablesthat associate the plurality of heterogeneous information sources anddata fields with one another, wherein the data integrator converts thecollected information into a plurality of predetermined electronic formsfor output according to a plurality of predetermined analysis and outputformats.
 2. The reporting system as defined in claim 1, wherein theinformation collected by the information retrieval system is retrievedand transferred for further processing and analysis.
 3. The reportingsystem as defined in claim 1, wherein the data integrator converts thecollected information into a predetermined electronic form.
 4. Thereporting system as defined in claim 1, wherein the data integratorintegrates the collected information to link to one or more of asubject, a category, and a data field.
 5. The reporting system asdefined in claim 1, wherein the data integrator further comprises a dataanalyzer that: analyzes and summarizes the collected information; andlocate duplicate data and eliminate redundancies.
 6. The reportingsystem as defined in claim 1, wherein the data integrator is configuredto consolidate data retrieved from the plurality of data sources intoone or more common records.
 7. The reporting system as defined in claim1, wherein the report generator outputs a display of the collectedinformation that is associated with a single subject.
 8. The reportingsystem as defined in claim 1, wherein the report generator outputs thecollected information via a display selected from the group consistingof a web-based interface, a locally accessed server, a desktopinterface, and a telecommunications access.
 9. A method comprisingaccessing, querying, identifying, and retrieving data from aconsolidation of information collected from a plurality of heterogeneousregulatory information data sources, wherein: receiving, from a userinterface, a query specification and a reporting specification;accessing data from a regulatory information data source selected fromthe group consisting of regulatory performance data, regulatorycompliance data, regulatory requirements data, and the combinationthereof; querying the accessed data according to the queryspecification, wherein identifying the queried data; retrieving theidentified data, wherein each data source within the consolidated has; apredetermined digital content and format; predetermined schema forinclusion in the consolidation; and predetermined indexing for usersearches; the method further comprising: converting the retrieved datainto the predetermined digital format, wherein the data, prior to theconverting the received data into the predetermined digital format, isin a published on a web page, the method further comprises: convertingthe data in the predetermined data field into a spreadsheet application;and converting the data in the table into predetermined data fieldswithin the consolidated regulatory information database; importing thedata in the predetermined digital format into an electronic database;and querying and reporting on the regulatory, data in the consolidateddatabase, wherein the reporting on the data in the consolidatedregulatory information database is according to a predetermined orcustomized user report specification, wherein, prior to the reporting,the further comprises removing duplicate data from the electronicdatabase; and performing authorization to access and retrieve data fromthe database of consolidated heterogeneous regulatory informationsources including local and web-based data sources, commercialdatabases, and hard copy documents.
 10. The method as defined in claim9, wherein the data, prior to the converting of the received data intothe predetermined digital format, is in a format selected from the groupconsisting of: a portable data format (PDF), a markup languageformation; selected from the group consisting of XML, HTML, andcombinations thereof; a word processing format; a spreadsheet format; agraphic format; a delimited text format; and a table published on a webpage.
 11. The method as defined in claim 9, wherein the predetermineduser specification is an indexed query topic selected from the groupconsisting of a person, a company, a product, a regulatory specialty andany combination thereof.
 12. The method as defined in claim 9, whereinthe predetermined user specification is a persons name, and the datacollected corresponds to the person and is selected from the groupconsisting of participation in a regulated activity, inspectionsconducted, regulatory documentation, regulatory orders, regulatorycommunications issued, scientific misconduct, debarment status,exclusion status, regulatory prosecutions, and combinations thereof. 13.The method as defined in claim 9, wherein the predetermined userspecification is an indexed query topic selected from the groupconsisting of a good, a service, a regulatory performance measure, andcombinations thereof.
 14. The method as defined in claim 9, wherein thepredetermined user specification is an indexed query topic selected fromthe group consisting of a regulated article, agency and combinationsthereof.
 15. The method as defined in claim 9, wherein the predetermineduser specification includes a limitation selected from the groupconsisting of: regulatory districts; regulatory jurisdictions, dates,and regulatory agency actions.